ASTM E1567-93(2001)
(Guide)Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations (Withdrawn 2010)
Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations (Withdrawn 2010)
SIGNIFICANCE AND USE
This guide is intended for use in designing laboratory, pilot plant, commercial production buildings that will use processes involving living organisms to produce products. These products are also manufactured under the FDA and other federal agency regulations.
These guidelines include the layout of facilities, design of containment areas, ventilation and air quality, personnel areas, special processing hazards, controlled environment areas, and other items.
This guide is for use by engineers, architects, and owners of biopharmatechnical manufacturing facilities to consider the special factors in laying out the facilities to meet cGMP requirements and other good engineering principles.
By using these guidelines along with other design criteria required by a variety of regulatory agencies, a validation effort can be achieved more easily to meet agency requirements and obtain operating permits.
This guide is intended to provide general guidelines for consideration and application in a variety of plant operations and processes in which the designers can make specific decisions concerning the exact architectural design features to use.
SCOPE
1.1 This guide covers architectural design considerations for buildings and facilities used in the biological processing industry to make drugs, chemicals, and other products.
1.2 These designs are intended to meet current good manufacturing practices (cGMP) criteria and guidelines published by the U.S. Food and Drug Administration (FDA) for processes and products manufactured under CFR Title 21.
1.3 While the guidelines described are general in nature, they are not expected to apply to all of the possible biotechnical processes used in the industry today. Accordingly, the user of this guide must exercise good engineering judgment in specific design applications to select the proper guidelines that apply.
1.4 In addition to the cGMP guidelines provided herein, other regulations and guides should be considered that are promulgated by other federal agencies such as the Occupational Safety and Health Administration (OSHA), the U.S. Environmental Protection Agency (EPA), the U.S. Drug Administration (USDA), the National Institute of Health (NIH), and so forth.
1.5 While the buildings will be designed to meet specific functional requirements and comply with local zoning ordinances, building codes, handicapped employee standards, and so forth, these considerations are not included in this guide.
1.6 The values stated in SI units are to be regarded as the standard.
1.7 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide covers architectural design considerations for buildings and facilities used in the biological processing industry to make drugs, chemicals, and other products.
Formerly under the jurisdiction of Committee E48 on Biotechnology, this guide was withdrawn in July 2010 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E1567–93 (Reapproved 2001)
Standard Guide for
Biopharmaceutical Facilities Architectural Design
1
Considerations
This standard is issued under the fixed designation E1567; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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1. Scope NIH Guidelines, Containment Area Designations
1.1 Thisguidecoversarchitecturaldesignconsiderationsfor
3. Terminology
buildings and facilities used in the biological processing
3.1 Definition:
industry to make drugs, chemicals, and other products.
3.1.1 cGMP—abbreviation for current good manufacturing
1.2 These designs are intended to meet current good manu-
practices as defined in CFR Title 21, Parts 210 and 211.
facturing practices (cGMP) criteria and guidelines published
bytheU.S.FoodandDrugAdministration(FDA)forprocesses
4. Significance and Use
and products manufactured under CFR Title 21.
4.1 This guide is intended for use in designing laboratory,
1.3 While the guidelines described are general in nature,
pilot plant, commercial production buildings that will use
theyarenotexpectedtoapplytoallofthepossiblebiotechnical
processes involving living organisms to produce products.
processes used in the industry today. Accordingly, the user of
TheseproductsarealsomanufacturedundertheFDAandother
this guide must exercise good engineering judgment in specific
federal agency regulations.
design applications to select the proper guidelines that apply.
4.2 These guidelines include the layout of facilities, design
1.4 In addition to the cGMP guidelines provided herein,
of containment areas, ventilation and air quality, personnel
other regulations and guides should be considered that are
areas, special processing hazards, controlled environment ar-
promulgated by other federal agencies such as the Occupa-
eas, and other items.
tional Safety and Health Administration (OSHA), the U.S.
4.3 This guide is for use by engineers, architects, and
Environmental Protection Agency (EPA), the U.S. Drug Ad-
owners of biopharmatechnical manufacturing facilities to con-
ministration (USDA), the National Institute of Health (NIH),
sider the special factors in laying out the facilities to meet
and so forth.
cGMP requirements and other good engineering principles.
1.5 While the buildings will be designed to meet specific
4.4 By using these guidelines along with other design
functional requirements and comply with local zoning ordi-
criteria required by a variety of regulatory agencies, a valida-
nances, building codes, handicapped employee standards, and
tion effort can be achieved more easily to meet agency
so forth, these considerations are not included in this guide.
requirements and obtain operating permits.
1.6 The values stated in SI units are to be regarded as the
4.5 This guide is intended to provide general guidelines for
standard.
consideration and application in a variety of plant operations
1.7 This standard does not purport to address all of the
and processes in which the designers can make specific
safety problems, if any, associated with its use. It is the
decisions concerning the exact architectural design features to
responsibility of the user of this standard to establish appro-
use.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
5. Summary of Guide
5.1 This guide provides architectural design principles to
2. Referenced Documents
consider when applying federal regulations to biopharmatech-
2.1 Code of Federal Regulations:
2 nical plant facilities construction and functions. Check lists for
CFR Title 21, Parts 58, 210, 211, 212, 606, 809, 820
specific plant operation activity areas presented with criteria
2.2 Other Document:
for their design and layout considerations. Environmental
considerations are also included for aseptic and special laminar
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ThisguideisunderthejurisdictionofASTMCommitteeE48onBiotechnology flow zones of operation. Fermenter area layout and space
and is the direct responsibility of Subcommittee E48.03 on Unit Processes and
considerations are presented. When containment and closed
Validation.
Current edition approved Aug. 15, 1993. Published October 1993. DOI:
10.1520/E1567-93R01.
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Available from Standardization Documents Order Desk, Bldg. 4, Section D, Available from National Institutes of Health, (NIH), 9000 Rockville Pike,
700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS. Bethesda, MD 20892.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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E1567–93 (2001)
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